CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 109 enrolled
Drug / intervention
Engerix™-Bbiological
Likely dose
Engerix™-B 10 milligram, 0, 1, and 2 month schedule with Month 12 booster; additional booster at Month 60 for 5-dose regimenAI-extracted
Key inclusion· 1
  • ✓Received at least one dose of study vaccine in the primary study (103860/064)
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00240500
NCT00240500Phase 4Completed
CompareCT.gov

Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers

GlaxoSmithKline·interventional·Posted Oct 18, 2005·Updated Dec 21, 2016

In Brief

A Phase 4 clinical trial evaluating Engerix™-B for Hepatitis B. Completed, enrolled 109 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2005
Enrollment StartOct 1, 2003
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.7 years ago

Interventions

Engerix™-Bbiological

In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.